Alzheimer's DiseaseNCT03233646
Retinal Imaging in Neurodegenerative Disease
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Duke University at 1 site in United States.
Trial summary
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment, Parkinson's Disease
- What is being tested?
- Retinal and Choroidal Imaging
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Neurology Clinics and the community.
Who may be able to join
- Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
- Adults without neurodegenerative disease
Who cannot join
- Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.
- Eyes that have had intraocular surgery, other than cataract surgery.
- If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Sharon Fekrat, MD FACS FASRS, 919-681-3937, imind@duke.edu
About this study
Official title: Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
Read the detailed description
Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.
The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.
This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.
The protocol for this study was amended and the record was updated accordingly.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment, Parkinson's Disease, Multiple Sclerosis, Huntington Disease, Lewy Body Dementia
- Being tested
- Retinal and Choroidal Imaging
- Keywords
- OCT angiography (OCTA), Optical Coherence Tomography (OCT), Vessel Density, Superficial Capillary Plexus, Retinal microvasculature, Scanning Laser Ophthalmoscopy, Ultra-widefield (UWF) Imaging, Perfusion Density, Retinal Nerve Fiber Layer, Ganglion Cell Inner Plexiform Layer, Choroidal Vascularity Index
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Parkinson Disease, Multiple Sclerosis, Huntington Disease, Lewy Body Disease, Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal and Choroidal ImagingDevice
Non-invasive OCT, OCTA, and UWF fundus photography of retina
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome) Receives: Device: Retinal and Choroidal Imaging | |
| Controls | Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis. Receives: Device: Retinal and Choroidal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ganglion cell-inner plexiform layer (GCIPL) thickness
Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula
Measured: Baseline, 1 year
Change in retinal nerve fiber layer (RNFL) thickness
Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula
Measured: Baseline, 1 year
Change in central subfield thickness (CST)
Central subfield thickness as measured on optical coherence tomography scan of macula
Measured: Baseline, 1 year
Change in choroidal vascularity index (CVI)
Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea
Measured: Baseline, 1 year
Change in foveal avascular zone (FAZ) area
Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula
Measured: Baseline, 1 year
Change in average perfusion density (PD)
Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Measured: Baseline, 1 year
Change in average vessel density (VD)
Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Measured: Baseline, 1 year
Change in average capillary perfusion density (CPD)
Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan
Measured: Baseline, 1 year
Change in average capillary flux index (CFI)
Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan
Measured: Baseline, 1 year
Secondary outcomes (3)
Change in retinal vessel tortuosity
Retinal vessel tortuosity measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
Measured: Baseline, 1 year
Change in retinal vessel width gradient
Retinal vessel width gradient measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
Measured: Baseline, 1 year
Change in retinal vessel fractal dimension
Retinal vessel fractal dimension measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start20 Jul 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh in Scotland, Tan Tock Seng Hospital in Singapore, Queens University of Belfast United Kingdom
- Responsible party
- Sponsor
- Investigators
- Sharon Fekrat, MD FACS FASRS, Principal investigator, Duke UniversityDilraj Grewal, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233646
- Sponsor's protocol ID
- Pro00111831
- Status last verified
- Feb 2026
- First submitted
- 26 Jul 2017
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhao W, Robbins CB, Grewal DS, Patel H, Soundararajan S, Liu AJ, Johnson KG, Agrawal R, Petrella JR, Stinnett SS, Parker D, Fekrat S. Correlating retinal and choroidal vascular parameters with volumetric MRI in Alzheimer's disease and amnestic mild cognitive impairment. BMC Ophthalmol. 2025 Jul 1;25(1):365. doi: 10.1186/s12886-025-04157-x.
PubMed 40598011Robbins CB, Akrobetu D, Ma JP, Stinnett SS, Soundararajan S, Liu AJ, Johnson KG, Grewal DS, Fekrat S. ASSESSMENT OF RETINAL MICROVASCULAR ALTERATIONS IN INDIVIDUALS WITH AMNESTIC AND NONAMNESTIC MILD COGNITIVE IMPAIRMENT USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2022 Jul 1;42(7):1338-1346. doi: 10.1097/IAE.0000000000003458.
PubMed 35723922
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study
- ClinicalTrials.gov ID
- NCT03233646
- Acronym / sponsor ID
- Pro00111831
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment, Parkinson's Disease, Multiple Sclerosis, Huntington Disease, Lewy Body Dementia
- Keywords
- OCT angiography (OCTA), Optical Coherence Tomography (OCT), Vessel Density, Superficial Capillary Plexus, Retinal microvasculature, Scanning Laser Ophthalmoscopy, Ultra-widefield (UWF) Imaging, Perfusion Density
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Edinburgh in Scotland, Tan Tock Seng Hospital in Singapore, Queens University of Belfast United Kingdom
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
Detailed description
Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.
The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.
This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.
The protocol for this study was amended and the record was updated accordingly.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Device: Retinal and Choroidal ImagingPatients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome) |
| Controls | – | Device: Retinal and Choroidal ImagingControls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Neurology Clinics and the community.
Key inclusion criteria (2 listed)
- Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
- Adults without neurodegenerative disease
Key exclusion criteria (3 listed)
- Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.
- Eyes that have had intraocular surgery, other than cataract surgery.
- If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal and Choroidal ImagingNon-invasive OCT, OCTA, and UWF fundus photography of retina | Device | Case, Controls |
Primary outcome
Change in ganglion cell-inner plexiform layer (GCIPL) thickness
Time frame: Baseline, 1 year
Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula
Change in retinal nerve fiber layer (RNFL) thickness
Time frame: Baseline, 1 year
Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula
Change in central subfield thickness (CST)
Time frame: Baseline, 1 year
Central subfield thickness as measured on optical coherence tomography scan of macula
Change in choroidal vascularity index (CVI)
Time frame: Baseline, 1 year
Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea
Change in foveal avascular zone (FAZ) area
Time frame: Baseline, 1 year
Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula
Change in average perfusion density (PD)
Time frame: Baseline, 1 year
Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Change in average vessel density (VD)
Time frame: Baseline, 1 year
Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula
Change in average capillary perfusion density (CPD)
Time frame: Baseline, 1 year
Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan
Change in average capillary flux index (CFI)
Time frame: Baseline, 1 year
Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan
3 secondary outcomes
Change in retinal vessel tortuosity
Time frame: Baseline, 1 year
Change in retinal vessel width gradient
Time frame: Baseline, 1 year
Change in retinal vessel fractal dimension
Time frame: Baseline, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 40598011Zhao W, Robbins CB, Grewal DS, Patel H, Soundararajan S, Liu AJ, Johnson KG, Agrawal R, Petrella JR, Stinnett SS, Parker D, Fekrat S. Correlating retinal and choroidal vascular parameters with volumetric MRI in Alzheimer's disease and amnestic mild cognitive impairment. BMC Ophthalmol. 2025 Jul 1;25(1):365. doi: 10.1186/s12886-025-04157-x.
- Derived from this study: PubMed 35723922Robbins CB, Akrobetu D, Ma JP, Stinnett SS, Soundararajan S, Liu AJ, Johnson KG, Grewal DS, Fekrat S. ASSESSMENT OF RETINAL MICROVASCULAR ALTERATIONS IN INDIVIDUALS WITH AMNESTIC AND NONAMNESTIC MILD COGNITIVE IMPAIRMENT USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2022 Jul 1;42(7):1338-1346. doi: 10.1097/IAE.0000000000003458.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharon Fekrat, MD FACS FASRS principal investigator
Duke University
Dilraj Grewal, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Fekrat, MD FACS FASRS (919-681-3937, imind@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ganglion cell-inner plexiform layer (GCIPL) thickness (time frame: Baseline, 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233646, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.